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Efficacy Study of a Ginger and Cardamom Gelatin for Xerostomy in Terminally Ill Patients

This study has been completed.
Information provided by (Responsible Party):
Teresa Peris, Mutuam Identifier:
First received: July 30, 2013
Last updated: February 10, 2014
Last verified: February 2014

Xerostomia or dry mouth is the subjective feeling that there is not enough saliva in your mouth. It's a frequent symptom in terminally ill patients receiving palliative care, reducing their quality of life and comfort. Usual recommendations in these patients are good oral hygiene and mouthwashes, ad libitum consumption of camomile and lemon juice infusions, and ad libitum sucking of cold (e.g. ice, ice cream) or citric products (e.g. pineapple). Other xerostomia treatments such as artificial saliva and pharmacological drugs (e.g. pilocarpine) are less used in terminally ill patients due to cost and secondary effects.

The purpose of this randomized parallel clinical trial is to determine if a new recipe of gelatin with orange juice, cardamome and ginger is more effective in the control of xerostomia than the usual treatment of camomile infusion with lemon juice against. Treatments will be consumed ad libitum during one week. The main outcome is the subjective assessment of dry mouth at end of treatment.

Condition Intervention
Xerostomia Salivary Gland Diseases Mouth Diseases Dietary Supplement: Cardamom, ginger and orange juice gelatin Dietary Supplement: Camomile infusion with lemon juice

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of a Ginger and Cardamom Gelatin Compared to a Camomile and Lemon Juice Infusion in Control of Xerostomy in Terminally Ill Patients

Resource links provided by NLM:

Further study details as provided by Teresa Peris, Mutuam:

Primary Outcome Measures:
  • Scale of self-perceived mouth dryness (0=not at all, 10=very dry) [ Time Frame: At end of treatment (1 week ) ]

Secondary Outcome Measures:
  • Objective signs of xerostomia [ Time Frame: At end of treatment (1 week ) ]
    Investigator will assess the presence of xerostomia signs through the assessment of 1) appearance and degree of dryness of tongue, buccal mucosa and lips, and 2)difficulties in speech derived from dry-mouth sensation in the patient.

  • Scale of subjective assessment of salival disfunction (Pai 2001). [ Time Frame: At end of treatment (1 week ) ]
  • Treatment acceptability [ Time Frame: At end of treatment (1 week ) ]
    Participants will answer an open-question regarding their satisfaction with the treatment received, with regards to taste, texture, difficulty of preparation, etc.

Enrollment: 32
Study Start Date: April 2013
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cardamom, ginger and orange juice gelatin
Dietary Supplement
Dietary Supplement: Cardamom, ginger and orange juice gelatin
Patients will receive the recipe of the gelatin, with detailed instructions to prepare it at home, and the necessary ingredients for the gelatin. If necessary, they will be helped in the preparation of an initial batch that should last for one week of treatment. Patients will be instructed to consume the gelatin candy as necessary to alleviate the dry mouth sensation
Active Comparator: Camomile infusion with lemon juice
Dietary Supplement
Dietary Supplement: Camomile infusion with lemon juice
Patients will receive instructions to prepare the infusion at home, and the necessary ingredients. Patients will be instructed to ingest the infusion as necessary to alleviate the dry mouth sensation.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years or older
  • Receiving palliative care for terminall illness at MUTUAM PADES
  • Complaining of dry mouth and should not have been treated for this problem
  • Able to prepare the study supplemental products by himself/herself or having a personal carer willing to do so

Exclusion Criteria:

  • Disease of oral mucosa (e.g. oral mycosis, coated oral cavity ).
  • Oropharinx neoplasm treated with surgery or radiotherapy.
  • Severe cognitive impairment (More than 7 errors in Pfeiffer scale)
  • Motor dysphagia causing coordination problems in swallowing.
  • Life expectancy less than seven days (Last Days Situation).
  Contacts and Locations
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Please refer to this study by its identifier: NCT01915966

Barcelona, Spain
Sponsors and Collaborators
Fundacio Salut i Envelliment UAB
Principal Investigator: Teresa Peris, RN Mutuam
  More Information

Responsible Party: Teresa Peris, Palliativa Care Nurse, Mutuam Identifier: NCT01915966     History of Changes
Other Study ID Numbers: FICE-MUT-02-1933-2013
Study First Received: July 30, 2013
Last Updated: February 10, 2014

Additional relevant MeSH terms:
Mouth Diseases
Salivary Gland Diseases
Stomatognathic Diseases processed this record on September 21, 2017